MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number	TMICL12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted and removed a 12.6mm tmicl12.6, -10.00/1.5/080 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os).The lens tore during injection.There was patient contact (lens touched the eye) with no patient injury.A back-up lens was implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: b5 - the reporter indicated that the surgeon implanted a 12.6mm tmicl12.6, -10.00/1.5/080 (sphere/cylinder/axis) implantable collamer lens, into the patient's left eye (os) on (b)(6) 2019.Lens flipped after insertion.Lens was removed intraoperatively.Lens tore before/during 2nd loading.There was patient contact (lens touched the eye) with no patient injury.The back-up lens was implanted on (b)(6) 2019.The lens implanted, removed, and replaced intraoperatively.This resolved the problem.Reportedly, "lens flipped after insertion, removed lens, when re-loading lens it ripped." (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned dry, inside a vial.Visual inspection found no visible damage to the lens and residue on the lens.Corrected data: d11 - injector model-msi-pf; lot#-unk should be removed as it is not applicable.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9664306
• Report Number: 2023826-2020-00243
• Device Sequence Number: 2667870
• Product Code: QCB
• UDI-Device Identifier: 00841542106856
• UDI-Public: 00841542106856
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: TMICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/04/2020; 02/12/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 02/05/2020; 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL#SFC-45, LOT#UNK; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK; INJECTOR MODEL#MSI-PF, LOT#UNK
• Patient Age: 22 YR